Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With OSAS

March 19, 2024 updated by: Xu J, Huai'an No.1 People's Hospital

Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With Obstructive Sleep Apnea Syndrome

It is thought that intermittent hypoxia, poor tissue oxygenation, and perfusion in OSA can lead to eNOS uncoupling. Uncoupled eNOS can reduce nitric oxide (NO), which will result in an imbalance of contraction and diastole. Furthermore, OSA may increase beat-to-to BPV via the characteristic acute blood pressure peaks that follow the end of obstructive apnoeas. Therefore, the aim is to discuss the relationship between vascular endothelial dysfunction and beat-to-beat blood pressure variability in patients with OSAS (Obstructive sleep apnea syndrome).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Obstructive sleep apnea (OSA) is characterized by recurrent airway collapse that causes chronic intermittent hypoxia(CIH). OSA is associated with systemic inflammation and oxidative stress resulting in endothelial dysfunction and cardiovascular disease (CVD). Under physiological conditions, eNOS is activated by shear stress and Ach. L-arginine and O2 are catalyzed by BH4, FMN, FAD, NADPH, and eNOS to produce nitric oxide (NO)， which has an important vasodilating effect， and L-citrulline. During the episode of OSA, intermittent hypoxia leads to oxidative stress resulting in the production of superoxide anions. The reaction between O2- and NO occurs rapidly, resulting in ONOO-. ONOO- and H2O2 oxidize BH4 to dihydrobiotrexate (BH2), which is a competitive inhibitor with BH4, thus limiting the availability of eNOS substrates and preventing NO production, resulting in an imbalance between contraction and diastolic. It has been documented that beat-to-beat blood pressure variability in OSAS patients is much higher than that in healthy adults. In some patients, intermittent hypoxia was observed with the episode of OSA, and blood pressure fluctuated with the episode of hypoxia. However, this was not found in the other patients, whose blood pressure did not change significantly during the hypoxia episode. Therefore, the investigators considered that the endothelial function of patients with high sensitivity to hypoxia was healthy or in the early stage, while the endothelial function of those patients with low sensitivity to hypoxia was at a relatively high level of impairment. Endothelial dysfunction can be measured indirectly by brachial artery flow-mediated dilation (FMD), beat-to-beat blood pressure variability can be measured by Polysomnography (PSG), and biological examinations can be performed by blood sampling. Thus, the purpose is to explore the specific relationship between OSAS beat-to-beat blood pressure variability and endothelial dysfunction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Outpatient snoring patients will have PSG, and patients aged 18 years and older will be included in the study.Inclusion Criteria:1. Moderate to severe OSA(AHI≥15 times/hour);2. Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);Exclusion Criteria:1.Malignant tumor, severe arrhythmia and heart disease, moderate and severe renal dysfunction, peripheral vascular disease, diabetes 2.Systolic blood pressure ≤140mmHg and diastolic blood pressure ≤90mmHg 3.Vigorous exercise 24 hours before the experiment; 4.Vasoactive drugs (ACEI, ARB, CCB, β blockers, nitrates) were used 48 hours before the experiment;

Description

Inclusion Criteria:

  1. ≥18 years old;
  2. Moderate to severe OSA(AHI≥15 times/hour);
  3. Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);

Exclusion Criteria:

  1. Malignant tumor, severe arrhythmia and heart disease, moderate and severe renal dysfunction, peripheral vascular disease, diabetes
  2. Systolic blood pressure ≤140mmHg and diastolic blood pressure ≤90mmHg
  3. Vigorous exercise 24 hours before the experiment;
  4. Vasoactive drugs (ACEI, ARB, CCB, β blockers, nitrates) were used 48 hours before the experiment;
  5. Smoking, drinking and consuming caffeinated beverages 12 hours before the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With OSAS
Time Frame: 2022.04.01-2023.04.01
the endothelial dysfucntion patients with OSAS have more sever blood pressure variability
2022.04.01-2023.04.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huai'an No.1 People's Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Huaian1PH3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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